Eli Lil­ly picks up an­oth­er Covid-19 EUA as reg­u­la­tors wave through its Olu­mi­ant plus remde­sivir com­bo

Eli Lil­ly has picked up an­oth­er win at the FDA, cross­ing the fin­ish line again in the Covid-19 treat­ment race de­spite some mixed da­ta. And the au­tho­riza­tion comes be­fore Re­gen­eron’s an­ti­body ther­a­py, which no­tably was used to treat Pres­i­dent Don­ald Trump back in Oc­to­ber, could pick up an EUA.

Reg­u­la­tors have giv­en the green light to Lil­ly’s Olu­mi­ant, in com­bi­na­tion with Gilead’s remde­sivir, to treat sus­pect­ed or con­firmed Covid-19 cas­es in both hos­pi­tal­ized adults and chil­dren over 2 that need sup­ple­men­tal oxy­gen, ven­ti­la­tors or life sup­port. The au­tho­riza­tion was based on da­ta show­ing the me­di­an time to re­cov­ery from Covid-19 was sev­en days on the com­bo vs. eight days for remde­sivir by it­self.

“Based on the FDA’s re­view of the to­tal­i­ty of the sci­en­tif­ic ev­i­dence avail­able, the agency has de­ter­mined that it is rea­son­able to be­lieve that baric­i­tinib, in com­bi­na­tion with remde­sivir, may be ef­fec­tive in treat­ing Covid-19 for the au­tho­rized pop­u­la­tion,” the FDA said in a state­ment.

A Lil­ly spokesper­son con­firmed to End­points News that the cock­tail will cost hos­pi­tals $150 per pa­tient per day for those with in­sur­ance.

Lil­ly re­vealed the da­ta back in Sep­tem­ber, defin­ing re­cov­ery as meet­ing the cri­te­ria for hos­pi­tal dis­charge. They fol­lowed up in Oc­to­ber say­ing the p-val­ue was 0.047, with the ben­e­fits be­ing most pro­nounced among pa­tients need­ing sup­ple­men­tal oxy­gen or non-in­va­sive ven­ti­la­tion at base­line.

The EUA comes amid broad­er ques­tions re­gard­ing remde­sivir’s ef­fec­tive­ness. No­tably, a WHO tri­al showed the an­tivi­ral didn’t have any sub­stan­tial ef­fect on im­prov­ing mor­tal­i­ty rates, re­duc­ing the amount of pa­tients need­ing ven­ti­la­tors or short­en­ing hos­pi­tal stays.

The FDA is­sued a full ap­proval for remde­sivir in late Oc­to­ber on the ba­sis of a sep­a­rate tri­al, where the drug had “mod­er­ate­ly re­duced time to re­cov­ery.” That study, the NI­AID-spon­sored Phase III ACTT-1 tri­al pub­lished on Oct 8, demon­strat­ed a re­duc­tion in re­cov­ery time by five days in hos­pi­tal­ized Covid-19 pa­tients and by sev­en days in pa­tients re­quir­ing oxy­gen.

Reg­u­la­tors did con­sid­er the WHO tri­al in its de­ci­sion to ap­prove remde­sivir, but said since Gilead’s ACTT-1 study was ran­dom­ized, dou­ble-blind­ed and place­bo-con­trolled where­as the WHO tri­al was open-la­bel, they found ACTT-1 to be “bet­ter suit­ed” in a time to re­cov­ery end­point.

Olu­mi­ant, al­so known as baric­i­tinib, is a JAK in­hibitor used to treat rheuma­toid arthri­tis, net­ting Eli Lil­ly near­ly $450 mil­lion through the first three quar­ters of 2020. It was the first drug the NIH test­ed in com­bi­na­tion im­me­di­ate­ly af­ter fin­ish­ing the remde­sivir tri­al.

This is the sec­ond EUA Lil­ly has re­ceived in as many weeks, with reg­u­la­tors au­tho­riz­ing one of the com­pa­ny’s neu­tral­iz­ing an­ti­body treat­ments less than ten days ago. Both Lil­ly and Re­gen­eron, which is de­vel­op­ing its own an­ti­body treat­ment, re­vealed they ap­plied for those EUAs on the same day.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.

Covid-19 roundup: Rus­sia prices vac­cine 't­wo or more times cheap­er' than mR­NA shots; Sino­vac PhI­II da­ta ex­pect­ed in ear­ly De­cem­ber

The world can now purchase its first registered vaccine — at less than $10 per dose.

RDIF, the Russian sovereign wealth fund and an avid backer of Sputnik V, said the vaccine will be available internationally starting from March 2021. A two-dose regimen of the adenovirus-based vaccine, which it has said is more than 90% effective, will cost less than $20.

And they are not shy about inserting themselves right into a rivalry with Western frontrunners, namely Pfizer/BioNTech and Moderna.

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Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.